Skin diseases and conditions, such as acne, dermatitis, rosacea, common warts, molluscum contagiosum, onychomycosis, and paronychia can be the result of a primary viral, bacterial or fungal infection and also can be further complicated by way of secondary or opportunistic microbial colonization and/or bacterial, fungal or viral infection. Despite the attempts made by the medical and pharmaceutical industry to develop treatments and drugs for these diseases and conditions, the causative agents have remained difficult to treat and the resulting diseases and conditions difficult to cure.
Acne
Acne is a well-known and common skin disease that can present in different forms as well as grades of severity, ranging from simple acne vulgaris to the more dangerous forms, such as acne conglobate, which can lead to severe disfigurements of the skin. Disregarding these conditions by forgoing treatment, or even improper or excessive treatment, can lead to irreversible scars and changes of the skin, and consequent adverse effects to quality of life.
Molluscum Contagiosum
Molluscum contagiosum (MC) is a viral infection of the skin. It is caused by a DNA poxvirus called the MC virus. The virus that causes MC spreads from direct contact person-to-person by touching the affected lesion. The disease may also be transmitted via fomites. The skin infection is most common in children and sexually active adults. MC can affect any area of the skin but is most common on the trunk of the body, arms, groin, and legs. MC is contagious until the lesions are resolved. Most lesions will resolve without treatment but can persist for years, if not treated. The average length of infection is between 6-18 months. Though there are many anecdotal remedies, none of them were shown to be effective in prospective clinical trials.
Onychomycosis
Onychomycosis—nail fungal infection—affects 30-60 million patients each year in the United States. It is the most common disease of the nails and constitutes about a half of all nail abnormalities. This condition may affect toenails or fingernails, but toenail infections are particularly common. The prevalence of onychomycosis is about 6-8% of the United States adult population. Common signs of onychomycosis include a thickened, yellow, or cloudy appearance of the nails. The nails can become rough and crumbly and can separate from the nail bed. Patients with onychomycosis may experience significant psychosocial problems due to the appearance of the nail.
The causative pathogens of onychomycosis include dermatophytes, Candida, and non-dermatophytic molds. Dermatophytes are the fungi most commonly responsible for onychomycosis in the temperate western countries, while Candida and non-dermatophytic molds are more frequently involved in the tropics and subtropics with a hot and humid climate. Trichophyton rubrum is a common dermatophyte involved in onychomycosis. Other dermatophytes that may be involved are T. mentagrophytes, Epidermophyton floccosum, T. violaceum, Microsporum gypseum, T. tonsurans, T. soudanense and the cattle ringworm fungus T. verrucosum. 
Candida spp. are known to cause fingernail onychomycosis in people whose hands are often submerged in water. Nondermatophytic molds, in particular members of the mold genera Scytalidium (now called Neoscytalidium), Scopulariopsis, and Aspergillus mainly affect people in the tropics, though it can persist if they later move to areas of temperate climate. Control of these pathogens can be used to treat onychomycosis.
Paronychia
Paronychia is one of the most common infections of the hand and nails. The entire nail plate is surrounded by the perionychium, which consists of proximal and lateral nail folds, and the hyponychium, the area beneath the free edge of the nail. Paronychias are localized, superficial infections or abscesses of the perionychium (epidermis bordering the nails). Paronychial infections develop when a disruption occurs between the seal of the proximal nail fold (commonly called the cuticle) and the nail plate that allows a portal of entry for invading organisms or irritants. Clinically, the disease referred to as paronychia is divided into acute paronychia (duration less than six weeks) or chronic paronychia (duration of the condition more than six weeks.) Paronychia associated with certain disease states and medication, particularly anti-cancer chemotherapeutics, can be extremely recalcitrant to treatment.
Acute Paronychia
Acute paronychia most commonly results from nail biting, finger sucking, aggressive manicuring, a hang nail or penetrating trauma, with or without a retained foreign body. The most common infecting organism is Staphylococcus aureus, followed by streptococci and pseudomonas organisms. Gram-negative organisms, herpes simplex virus, dermatophytes and yeasts have also been reported as causative agents. Children are prone to acute paronychia through direct inoculation of fingers with flora from the mouth secondary to finger sucking and nail biting. Patients with acute paronychia may report localized pain and tenderness of the perionychium. The perionychial area usually appears erythematous and inflamed, and the nail may appear discolored and even distorted. If left untreated, a collection of pus may develop as an abscess around the perionychium. Fluctuance and local purulence at the nail margin may occur, and infection may extend beneath the nail margin to involve the nail bed. Conservative treatment, such as warm-water soaks three to four times a day, may be effective early in the course if an abscess has not formed. Clindamycin (Cleocin) and the combination of amoxicillin-clavulanic acid (Augmentin) are effective against most pathogens isolated from these infections. When abscess or fluctuance is present, efforts to induce spontaneous drainage or surgical drainage become necessary.
Chronic Paronychia
Chronic paronychia resembles acute paronychia clinically, but the cause is multi-factorial. Chronic paronychia is usually non-suppurative and is more difficult to treat. For irritant-induced chronic paronychia, people at risk include those who are repeatedly exposed to water containing irritants or alkali, and those who are repeatedly exposed to moist environments. Persons at high risk include bartenders, housekeepers, homemakers, dishwashers and swimmers, as well as diabetic and immunosuppressed persons. Diseases associated with paronychia include autoimmune bullous disorders, psoriasis, and lichen planus. Paronychia is a well-known side effect of numerous targeted anticancer therapies, with Epidermal Growth Factor Inhibitors being the most widely reported causative class. Chronic paronychia usually causes swollen, red, tender and boggy nail folds. Symptoms are typically present for six weeks or longer. Fluctuance is rare, and there is less erythema than is present in acute paronychia. Candida albicans may be cultured from 95 percent of cases of chronic paronychia. Other pathogens, including atypical mycobacteria, gram-negative rods and gram-negative cocci, have also been implicated in chronic paronychia. Treatment of chronic paronychia primarily involves avoiding predisposing factors such as exposure to irritating substances, prolonged exposure to water, manicures, nail trauma and finger sucking. Treatment with a combination of topical steroids and an antifungal agent has been shown to be successful. Oral antifungal therapy is rarely necessary. Treatment of potential secondary bacterial infections with antibacterial solutions or ointments, acetic acid soaks (1:1 ratio of vinegar to water) or oral antibiotics may be necessary. Surgical intervention is indicated when medical treatment fails. Excellent results have been reported with the use of an eponychial marsupialization technique, as well as removal of the entire nail and application of an antifungal-steroid ointment to the nail bed.
Paronychia is Increasing with Newer Cancer Therapies
Overexpression of the epidermal growth factor receptor (EGFR) is strongly associated with cancer development and progression of a number of malignancies. EGFR inhibitors (EGFRI) are targeted agents used for treating lung (erlotinib), pancreatic (erlotinib in combination with gemcitabine), breast (lapatinib in combination with capecitabine or anastrozole), head and neck (cetuximab in combination with radiotherapy), and colorectal cancers (cetuximab, panitumumab)i. EGFRI may be used as first-line through third-line treatments, alone or in combination with other agents in the aforementioned cancers. Commonly experienced dermatologic side effects include papulopustular (acneiform) rash, hair changes, radiation dermatitis enhancement, pruritus, mucositis, xerosis/fissures, and paronychia. Incidences of these side effects are frequent. When severe, dermatologic toxicities may to lead to dose modification or discontinuation. Although the side effect profile may be primarily dermatologic, toxicities result in significant physical and emotional discomfort, thus it is critical to maximize supportive measures. EGFRI therapies are being used with increasing frequency for cancer because they are specifically targeted molecular therapies for individual cancer subsets that avoid the use of more toxic broad-sweeping chemotherapies. Because numerous structures in the epidermis (or superior most layer of the skin) share similar receptors, they have well-known side effects that result. Many patients on EGFRI therapy develop paronychia, which results in increased financial burden on the health care system. All patients receiving EGFRIs are at risk for developing nail changes, which typically develop after two or more months of chemotherapy exposure. Resultant onycholysis or onychodystrophy may result as a secondary process from the presence of nail matrix inflammation. Fingernails and toenails may be affected, with the first digits most commonly affected. Precedent trauma is not believed to be causative but rather an aggravating factor. Morbidity is high, leading to significant pain, functional limitation, and impairment of activities of daily living. There are no approved treatments for EGFRI-associated nail changes. Similarly, there have been no randomized controlled studies until our study described below evaluating therapies for paronychia. Management strategies are aimed at minimizing periungual trauma, decreasing periungual inflammation, preventing superinfection, and eliminating excessive granulation tissue. EGFRI are not the only class of medications to induce paronychia, as many other cancer chemotherapies and immunotherapies can cause chemotherapy-induced paronychia.
Dimethyl Sulfoxide (DMSO)
Dimethyl sulfoxide (DMSO) is a polar aprotic solvent that dissolves both polar and nonpolar compounds and is miscible in a wide range of organic solvents as well as water. It has a relatively high melting point.
DMSO has been used in medicine since the 1960's following the discovery that it could penetrate the skin without damage and could carry small molecules into a biological system. DMSO is predominantly used as a topical analgesic, a vehicle for topical application of pharmaceuticals, as an anti-inflammatory, and an antioxidant.
DMSO has been examined for the treatment of numerous conditions and ailments, but the U.S. Food and Drug Administration (FDA) has approved its use only for the symptomatic relief of patients with interstitial cystitis. A gel containing DMSO and two additional active ingredients, namely, dexpanthenol and heparin, is sold in Germany and eastern Europe for topical use in sprains, tendinitis, and local inflammation. DMSO is also marketed as an alternative medicine.
DMSO solution is commonly used in veterinary medicine as a liniment for horses, alone or in combination with other ingredients to carry those other ingredients across the skin. DMSO is used intravenously, alone or in combination with other drugs for the treatment of increased intracranial pressure and/or cerebral edema in horses.
According to WebMD (https://www.webmd.com/vitamins/ai/ingredientmono-874/dmso-dimethylsulfoxide) DMSO is available as a prescription medicine and dietary supplement and is most commonly used for bladder inflammation (interstitial cystitis).
DMSO is possibly effective for a chronic pain condition called complex regional pain syndrome, skin and tissue damage caused by chemotherapy when it leaks from the IV, and in combination with another active ingredient, e.g., idoxuridine, to reduce lesions and swelling and pain associated with shingles.
Research has shown that DMSO is likely ineffective for scleroderma or for treatment of cancer, but may have some effect for treating amyloidosis, bile duct stones, diabetic foot ulcers, high blood pressure in the brain, arthritis, stomach ulcers caused by Helicobacter pylori, tendinopathy, asthma, eye problems, gall stones, headaches, muscle problems, and calluses.
These prior uses of DMSO have employed a variety of compositions known in the art. For example, a cream containing 50% DMSO has been used for treating complex regional pain syndrome. For prevention of skin and tissue damage caused by chemotherapy agents leaking from the IV, a dressing containing 77% to 90% DMSO solution has been applied to the skin at the site of IV administration. For rash caused by shingles (herpes zoster), a composition of 5% to 40% idoxuridine in DMSO has been applied every 4 hours for 4 days or until the skin starts to heal. For painful bladder (interstitial cystitis) or inflammatory bladder disease, undiluted DMSO solution is administered as a drip using a catheter.
Heretofore, a topical composition comprising DMSO as the sole effective agent has not been described for treatment and cure of acne, dermatitis, rosacea, common warts, molluscum contagiosum, onychomycosis, or paronychia. More particularly, a topical gel composition comprising less than 50% DMSO and a gelling agent in aqueous solvent has not been described for treating or curing these skin diseases or conditions.
What is needed is a composition which can provide effective treatment and cure of one or more skin conditions or diseases caused by viral, bacterial or fungal infections, or complicated by secondary or opportunistic microbial colonization infection. Such composition can be advantageous for treating or curing acne, dermatitis, rosacea, common warts, molluscum contagiosum, onychomycosis, or paronychia.